In a first aspect, the present invention relates to a method of testing a fluidic system. The method comprising applying a fluid with an input fluidic characteristic to the fluidic system, while the fluidic system is in a first configuration, and measuring an output fluidic characteristic. The method also comprises comparing the measured output fluidic characteristic to a reference. In a further aspect the present invention relates to a testing system configured for testing a fluidic system.

Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.

The present invention relates to method of using spectroscopy for real time measuring of concentration of desired product and using measured data for monitoring and control of chromatography. It develops a method and system for measuring real-time concentration of clarified harvest and that of flow through of loading step of the chromatography and using measured data for determining breakthrough in real-time. The two modes of operation are used viz. first mode (Part A) uses a single near infrared spectroscopy (NIR) flow cell prior to the continuous chromatography column to ensure optimal loading in each cycle based on dynamic binding capacity studies carried out previously with the desired Protein A resin and second mode (Part B) uses two near infrared spectroscopy (NIR) flow cells, one before and one after the column, to detect the breakthrough curve (from 1% breakthrough onwards).

A method of operating a chromatography column is described. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value.

An analysis device having a liquid chromatograph prevents a plurality of streams from being unusable at the same time Whether a usable stream is 0 or not among streams 1, 2, and 3 is determined. In a case where none of the streams is usable, the control unit skips a sample introduction in the cycle; and where there is one usable stream in the cycle, the stream is used. In a case where there are multiple streams that are usable in the cycle, and there are multiple streams of which the remaining number of uses of a separation column is the minimum, the stream having the smallest stream number is used; and where there is one stream of which the remaining number of uses of a separation column is the minimum, the stream to which the separation column having the minimum remaining number of uses is connected and used.

An analysis system includes: a storage that obtains resolutions of a column for separating a component in a sample gas and stores each of the resolutions in association with a specific time; and a processor that predicts a state of the column based on resolution data indicating the restored resolutions.

An analysis assistance device includes an estimator that estimates distribution of measurement quality index data using a plurality of analysis condition data to be provided to an analysis device and a plurality of measurement data obtained in the analysis device based on the plurality of analysis condition data, and a measurement quality index outputter that outputs for display a region where the measurement quality index data is not less than a predetermined threshold value as a design space, and the measurement quality index outputter outputs the region of the design space in an enlarged manner by cutting off at least part of a region other than the design space in a distribution region of the measurement quality index data.

The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.

A non-transitory computer readable medium (CRM) storing computer readable program code for monitoring a state of a chromatography apparatus embodied therein that: receives one or more monitoring conditions that each include a determination condition for parameters related to measurements taken using the chromatography apparatus; and displays, in parallel and using a combination operational expression: a first conditional expression based on at least one of the monitoring conditions that make up a first combined conditional expression, wherein the first combined conditional expression is based on a first combined monitoring condition that combines all of the received monitoring conditions, and a second conditional expression based on at least one of the monitoring conditions associated with the first conditional expression.

An apparatus for performing liquid chromatography includes a chromatography column, and an insulating member surrounding the chromatography column wherein the insulating member is formed from a vacuum chamber surrounding the chromatography column. Another apparatus for performing liquid chromatography includes a chromatography column, and an insulating member surrounding the chromatography column, wherein the insulating member includes aerogel. Also described is a method of insulating a chromatography column comprising forming a jacket surrounding the chromatography column, and creating a vacuum chamber in an area between the jacket and the chromatography column.